Skip to content

Piccolo Composite Plate System Distal Femur Plate

by Carbofix Orthopedics Ltd 12 variants

Ref DFELN1808

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011020CARBOFIX012UJ Basic UDI-DI 07290109335216UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290109335216 UDI-DI Date19 Oct 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Piccolo Composite ® Distal Femur Plate EUDAMED
Piccolo Composite Plate System GUDID
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Device Name
Distal Femur Plates
Model / Ref / Catalog
DFELN1808, Distal Femur Plate
Primary DI / UDI-DI
07290109335216
Basic UDI-DI
729011020CARBOFIX012UJ
510(k) Number
FDA Product Code
HRS, KTT
EMDN Code
P09120599 Bone fixation plates - other
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 207 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DFELN1808
GUDID
Distal Femur Plate
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K143496)

Show all (12)

Other devices from Carbofix Orthopedics Ltd

See all devices from Carbofix Orthopedics Ltd →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No